Baldus Sedation GmbH & Co. KG
DE-MF-000006223 · Germany · Bendorf
Baldus Sedation GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 27 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: Baldus Analog, Baldus Doppelnasenmasken-Scavengersystem, Baldus Mobile E-Stand, Baldus Touch.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- Baldus Analog O2-N2O Mixer for Analgesia 50
- Baldus Analog O2-N2O Mixer for Analgesia 60
- Baldus Doppelnasenmaske Pediatric, autoklavierbar
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Blueberry Dance
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Chilla Vanilla
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Happy Apple
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Pure Ghost
- Baldus Doppelnasenmasken (Single Use), Adult, Scent Strawberry Delight
- Baldus Doppelnasenmasken (Single Use), Pediatric, Scent Blueberry Danc
- Baldus Doppelnasenmasken (Single Use), Pediatric, Scent Chilla Vanilla
- Baldus Doppelnasenmasken (Single Use), Pediatric, Scent Strawberry Del
- Baldus Scavenger System, autoklavierbar, Inhalt: Doppelschlauch mit 2
Showing 12 of 33 declared devices.
Catalogue references include 16004, 16009-50, 16030-AE, 16030-AV, 16030-PE, 16030-PV.
European nomenclature codes declared: R030199, R9099, R020199, R9080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Baldus Sedation GmbH & Co. KG (DE) · FDA 3011780089 |
| Devices in EUDAMED | 33 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 63.6 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Baldus Sedation GmbH & Co. KG is registered in the United States but was not found in the Canadian register.